UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A prospective study analyzing heart rate variability with combined spinal and epidural analgesia for labor analgesia
Title of the study (Brief title)	Comparison of maternal heart rate variability before and after combined spinal and epidural analgesia
Region	Japan

Condition
Condition	Pregnancy
Classification by specialty	Obsterics and gynecology Anesthesiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	This study aimed to compare heart rate variability before and after spinal analgesia for women undergoing labor analgesia with combined spinal and epidural analgesia and to investigate the extent to which spinal analgesia affects autonomic nervous activity balance at induction of labor analgesia.
Basic objectives2	Others
Basic objectives -Others	Changes in heart rate variability (mainly low-frequency: LF/high-frequency: HF) were compared as autonomic nervous activity balance at induction of labor analgesia.
Trial characteristics_1	Confirmatory
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	LF/HF rate change before and after spinal analgesia for labor.
Key secondary outcomes	Comparison of LF/HF rate change before and after spinal analgesia between cases with and without fetal heart rate deceleration at induction of labor analgesia.

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	Not applicable
Age-upper limit	Not applicable
Gender	Female
Key inclusion criteria	Patients who requested labor analgesia with combined spinal and epidural analgesia and consented to participate in the study
Key exclusion criteria	1.If a labor analgesia with combined spinal and epidural analgesia was contraindicated because of hematologic diseases or other reasons 2.If the patient did not wish to undergo combined spinal and epidural analgesia
Target sample size	100

Research contact person
Name of lead principal investigator	SHUNSUKE HYUGA
Organization	Kitasato University
Division name	Anesthesiology, School of Medicine
Address	1-15-1 Kitasato Minami-ku, Sagamihara City, Kanagawa
TEL	042-778-8606
Email	shyuga@kitasato-u.ac.jp

Public contact
Name of contact person	SHUNSUKE HYUGA
Organization	Kitasato University
Division name	Anesthesiology, School of Medicine
Address	1-15-1 Kitasato Minami-ku, Sagamihara City, Kanagawa
TEL	042-778-8606
Homepage URL
Email	shyuga@kitasato-u.ac.jp

Sponsor
Institute	Kitasato University
Institute
Department

Funding Source
Organization	Kitasato University
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	北里大学病院（神奈川県）

Other administrative information
Date of disclosure of the study information	2016 Year 03 Month 25 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2016 Year 02 Month 05 Day
Anticipated trial start date	2016 Year 02 Month 05 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	1.Prospective observational study 2.March 2016 - December 2018 3.Recruitment of subjects:Pregnant women who is admitted to our hospital and meet the selection criteria. 4.We corect and analyse that HRV,age, weight, height, BMI, gestational age, Visual analog scale of pain at the time of anesthesia enforcement (VASP), VASP after anesthesia enforcement, HF, LF, cold sensation loss or decrease in the scope of the post-anesthesia, non-invasive blood pressure, oxygen saturation, heart rate, fetal heart rate and uterine contraction interval and a strength.We use HRV analysis device. HRV was analyzed at 0,5,10,15, and 30 min after injections of analgesics in the lateral position.

Management information
Registered date	2016 Year 03 Month 23 Day
Last modified on	2018 Year 12 Month 16 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024882